Trial Outcomes & Findings for Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study (NCT NCT03738332)

NCT ID: NCT03738332

Last Updated: 2022-02-01

Results Overview

Number of participants who consented the study and number of participants who enrolled in the study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Approximately 5-month recruitment window
• Results posted on: 2022-02-01

Participant Flow

Participant milestones

Measure	Low-level Laser Therapy Single arm Low-Level Laser: Low-level laser therapy Dose: twice a week for 6 weeks (12 sessions)
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Low-level Laser Therapy Single arm Low-Level Laser: Low-level laser therapy Dose: twice a week for 6 weeks (12 sessions)
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study

Baseline characteristics by cohort

Measure	Low-level Laser Therapy n=12 Participants Single arm Low-Level Laser: Low-level laser therapy
Age, Continuous	58.4 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 5-month recruitment window

Number of participants who consented the study and number of participants who enrolled in the study

Outcome measures

Measure	Low-level Laser Therapy n=30 Participants Single arm Low-Level Laser: Low-level laser therapy
Number of Participants Consented and Enrolled in Study	12 Participants

PRIMARY outcome

Timeframe: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

Number of participants who completed the study visits

Outcome measures

Measure	Low-level Laser Therapy n=12 Participants Single arm Low-Level Laser: Low-level laser therapy
Number of Participants Completed the Study Visits	11 Participants

PRIMARY outcome

Timeframe: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

Number of participants who experienced adverse events during the course of the study.

Outcome measures

Measure	Low-level Laser Therapy n=12 Participants Single arm Low-Level Laser: Low-level laser therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: at 4-week post-intervention visit

Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).

Outcome measures

Measure	Low-level Laser Therapy n=11 Participants Single arm Low-Level Laser: Low-level laser therapy
Number of Participants Who Were Satisfied With Study Intervention.	11 Participants

Adverse Events

Low-level Laser Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jie Deng

University of Pennsylvania

Phone: 215-573-2393

Email: jiedeng@nursing.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place